Cleared Special

K080423 - INTEGRE

K080423 is an FDA 510(k) clearance for INTEGRE, manufactured by Ellex Medical Pty, Ltd.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Special 510(k) pathway after a 25-day FDA review.

K080423 · Ellex Medical Pty, Ltd. · Ophthalmic device
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Mar 2008
Decision
25d
Days
Class 2
Risk

K080423 is an FDA 510(k) clearance for the INTEGRE, MODEL LP581. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Ellex Medical Pty, Ltd. (Adelaide, South Australia, AU). The FDA issued a Cleared decision on March 11, 2008 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ellex Medical Pty, Ltd. devices

FDA 510(k) Submission Details - K080423

510(k) Number K080423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2008
Decision Date March 11, 2008
Days to Decision 25 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 110d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQF Laser, Ophthalmic

All 86
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